Standrd of Care treatment ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
64血栓性血小板減少性紫斑病1

64. 血栓性血小板減少性紫斑病


臨床試験数 : 92 薬物数 : 85 - (DrugBank : 21) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 76
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-JapicCTI-194991
20/10/201908/10/2019A phase 3, randomized, controlled study of prophylactic and on-demandA phase 3, prospective, randomized, controlled, open-label, multicenter, 2 period crossover study with a single arm continuation evaluating the safety and efficacy of BAX 930 (rADAMTS13) in the prophylactic and on-demand treatment of subjects with severe congenital thrombotic thrombocytopenic purpura (cTTP, Upshaw-Schulman Syndrome [USS], hereditary thrombotic thrombocytopenic purpura [hTTP]) severe congenital thrombotic thrombocytopenicpurpura (cTTP, Upshaw-Schulman Syndrome [USS],hereditary thrombotic thrombocytopenic purpura [hTTP]Intervention name : rADAMTS-13
INN of the intervention : -
Dosage And administration of the intervention : BAX930 is to be reconstituted using all the amount of the accompanying water for reconstitution and injected or dripped slowly intravenously. Normally, 40 (+/-4) international units per kg of body weight is administered at intervals of 1 to 2 weeks or according to the patient's symptoms. The frequency of dosing and dose level can be increased or decreased as appropriate according to the patient's symptoms.
Control intervention name : Standrd of Care treatment
INN of the control intervention : -
Dosage And administration of the control intervention : -
Baxalta now part of Shire(ICCC: IQVIA Services Japan K.K.)NULLrecruiting070BOTH4Phase 3Japan, North America, Europe